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Controlled Environment Assembler

2 months ago

Oklahoma City, Oklahoma, United States JobRialto Full time

Position Overview:

The primary responsibility of a Cleanroom Assembler is to execute light assembly, ensure cleanliness, inspect, and package products within a controlled setting or designated area, such as a non-sterile packaging station.

This role may also encompass boxing and palletizing finished products, preparing them for release as either non-sterile or sterile items. Adherence to all governing regulations, including company policies and safety protocols, is essential in maintaining a clean and safe work environment.

Key Responsibilities:

(80%) Assemble and package medical products utilizing various methods:

- Interpret product specifications and blueprints.
- Confirm component counts, quantities, and revisions.
- Clean components in preparation for packaging.
- Assemble products through bonding, winding, crimping, pressing, splitting, cutting, etc.
- Generate and affix labels for proper material identification.
- Seal products using diverse heat-sealing machines and materials such as Tyvek, mylar, PET, PEG, foil, non-sterile plastic, and blister packaging configurations.
- Box and prepare products for shipment to sterilization facilities.

(10%) Additional Duties:

- Assist with rework as necessary.
- Collaborate with quality/materials teams to trim or sort components.
- Undertake other related tasks as assigned.

(5%) Documentation Compliance:

- Complete and comprehend necessary documentation to align with company policies, Quality Manual, and procedures, including FDA, QSR, and various domestic and international standards.
- Execute work transactions and barcode scanning as applicable.

(5%) Team Collaboration:

- Engage in effective communication, both verbal and written.
- Demonstrate active listening, collaboration, and positive interpersonal relations.

Qualifications:

- High School diploma or equivalent required.
- Previous experience in cleanroom or medical packaging preferred.

Skills:

- Ability to assemble and manage small components.
- Proficiency in reading and writing English, along with basic math skills.